510(k) · Cleared
ClearedHI-Torque Balance Iniversal Guide Wire with Hydrocoat Hydrophilic Coating
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Guidant Corp. · DQX Wire, Guide, Catheter
Cleared on Aug 26, 2003 as substantially equivalent to K013833 (Guidant Corp., 2002) after an 88-day review. Its family tree reaches back 4 generations to 1991. 3 later devices descend from it.
- Decided
- Aug 26, 2003
- Review
- 88 days
- Class
- Class II
- Product code
- DQX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K913353 (1991). 7 ancestors in all. 3 later devices descend from it, 1 citing it directly.
- Root · 4 generations backK913353 Vascular Guide WireAdvanced Cardiovascular Systems, Inc. · 1991
- 3 generations backK971815 Asc Balance Middleweight Guide WireGuidant Corp. · 1997
- 2 generations backK973494 HI-Torque Balance Guide Wire with Hydrocoat Hydrophilic Coating, Acs…Guidant Corp. · 1997
- 1 generation backK013833 HI-Toque Balance Middleweight Universal Guide Wire with Hydrocoat…Guidant Corp. · 2002
- This deviceK031678 HI-Torque Balance Iniversal Guide Wire with Hydrocoat Hydrophilic…Guidant Corp. · 2003
- Descendant · cites it directly · 2 of its ownK152709 HI-Torque BalanceAbbott Vascular · 2015
- Descendant · 2 generations on · 0 of its ownK182553 Inno-PathwireSuzhou Innomed Medical Device Co., Ltd. · 2019
- Descendant · 2 generations on · 0 of its ownK173052 Heraeus TMW GuidewireHeraeus Medical Components, LLC · 2017
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K913353 | Vascular Guide Wire | Advanced Cardiovascular Systems, Inc. | 1991 | — |
| −3 | K971815 | Asc Balance Middleweight Guide Wire | Guidant Corp. | 1997 | — |
| −2 | K973494 | HI-Torque Balance Guide Wire with Hydrocoat Hydrophilic Coating, Acs HI-Torque… | Guidant Corp. | 1997 | — |
| −1 | K013833 | HI-Toque Balance Middleweight Universal Guide Wire with Hydrocoat Hydrophilic… | Guidant Corp. | 2002 | — |
| 0 (this device) | K031678 | HI-Torque Balance Iniversal Guide Wire with Hydrocoat Hydrophilic Coating | Guidant Corp. | 2003 | — |
| +1 | K152709 | HI-Torque Balance | Abbott Vascular | 2015 | — |
| +2 | K182553 | Inno-Pathwire | Suzhou Innomed Medical Device Co., Ltd. | 2019 | — |
| +2 | K173052 | Heraeus TMW Guidewire | Heraeus Medical Components, LLC | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 1995 | 1 | 0 |
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2017 | 1 | 0 |
| 2019 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in DQX? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new DQX device
- #1 K213854 SavvyWirescore 15.7 · 10 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K013833 | HI-Toque Balance Middleweight Universal Guide Wire with Hydrocoat Hydrophilic Coating…Summary page 1…e: HI-TORQUE BALANCE MIDDLEWEIGHT (BMW) UNIVERSALTM Guide Wire with Hydrocoat Hydrophilic Coating (K013833) 11. Device Description: The HI-TORQUE BALANCE UNIVERSALTMGuide Wire is a steerable guide wire available in a maximum diameter… | 2002 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K152709 | HI-Torque Balance | 2015 | 2 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 12 years and passes through 2 companies; a new generation was cleared every 4.1 years on median.
- None of the 7 ancestors has a recall.
- Of its descendants, K152709 (Abbott Vascular, 2015) has gone furthest, with 2 descendants of its own.
- 5 other devices also cite its predicate K013833.
How does its category compare?
All DQX devicesDQX Wire, Guide, Catheter: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DQX
10in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DQX
177in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DQX
3in 2024
Class I (8 since 2007) Class II/III not classified
Adverse event reports per year · DQX
2,178in 2025
MAUDE reports naming product code DQX, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 14 | 85 | 12 | 760 |
| 2008 | 19 | 87 | 7 | 715 |
| 2009 | 18 | 87 | 49 | 687 |
| 2010 | 21 | 63 | 34 | 987 |
| 2011 | 18 | 43 | 3 | 1,311 |
| 2012 | 20 | 62 | 5 | 1,337 |
| 2013 | 18 | 119 | 7 (4) | 1,474 |
| 2014 | 18 | 103 | 0 | 1,323 |
| 2015 | 15 | 112 | 1 | 1,323 |
| 2016 | 14 | 179 | 2 (2) | 1,466 |
| 2017 | 19 | 85 | 17 | 1,524 |
| 2018 | 19 | 114 | 9 | 1,737 |
| 2019 | 13 | 173 | 2 | 1,679 |
| 2020 | 14 | 106 | 1 (1) | 1,536 |
| 2021 | 6 | 161 | 0 | 1,713 |
| 2022 | 15 | 212 | 0 | 1,647 |
| 2023 | 10 | 136 | 0 | 2,068 |
| 2024 | 11 | 134 | 3 | 2,210 |
| 2025 | 10 | 177 | 0 | 2,178 |
| 2026 | 12 | 145 | 4 (1) | — |
What is it indicated for?
To facilitate the placement of balloon dilatation catheters during percutaneous transluminal coronary angioplasty (PTCA), percutaneous transluminal angioplasty (PTA) and compatible stent devices during therapeutic intravascular procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K031678 · printed Nov 6, 2026
Cite this page
510(k) Report. “K031678: HI-Torque Balance Iniversal Guide Wire with Hydrocoat Hydrophilic Coating.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K031678
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026